Bellevue Hospital: The Birthplace of Formulary Medicine?

New York City can claim an impressive, albeit eclectic, list of historical firsts. In 1789, the metropolis served as the first capital of the United States. Perhaps to ensure legislators didn't get too thirsty, the city also was the first to open a public brewery. The first Yiddish newspaper was published in the Big Apple, and the city hosted the first meeting of the Boys Club of America.

But did you know that the ancestor of today's drug formulary was born in the mid-19th century, based on the efforts of a consortium led by New York City's Bellevue Hospital?

"The original idea was similar [to today's formularies], but there weren't many medicines then," noted Joseph Deffenbaugh, MPH, RPh, Director of Public Health and Quality for the American Society of Health-System Pharmacists. "Apothecaries, who evolved to become pharmacists, compounded from raw ingredients--mainly plant and animal extracts and a few chemicals, including paregoric, belladonna and digitalis. Opium-derived painkillers were the most useful treatments."

Historically, both apothecaries and physicians compounded medicines. Sometimes doctors would even carry boxes of ingredients so that they could compound on-site during house calls. As hospitals began sharing formulas developed by individuals for making their own medicines, concern arose about which drug materials to use for particular kinds of patients. "Physicians and, later, pharmacists formed hospital committees to assess therapeutic agents that were the most appropriate to have available to treat that hospital's patients," Mr. Deffenbaugh said. The committees, he added, "were the precursors to today's Pharmacy & Therapeutics Committees or the Drug Use Policy Commission, among other names."

Gradually, the original consortium (Bellevue Hospital and Columbia, Cornell and New York University Colleges of Medicine) dissolved. Bellevue, increasingly uneasy about the minimal controls on drug production, safety and efficacy in the United States, then created a Formulary Committee--believed to be the first--in the mid-1930s. Although other institutions later established similar bodies, Bellevue's committee is the longest continuously running group.

"It was one single committee, which was revolutionary at the time," according to Robert S. Holzman, MD, Hospital Epidemiologist at Bellevue Hospital and Chairman of its Committee on Drugs & Formulary from 1982 to 2003. "Ours was a multidisciplinary group, with pharmacists, chemists and pharmacologists. Over time, the physicians took on a leading role."

Initially, the focus was on ensuring quality and efficacy of each drug. Later, the committee began evaluating efficacy alone, as compared to cost plus efficacy. One evolving role of Bellevue's formulary was "to identify certain people who could safely use specific drugs," said Dr. Holzman, its co-chair from 1979 to 1982. "The committee decided the hospital would restrict its formulary to drugs of known composition and established efficacy, excluding medicines with secret or proprietary mixtures. This spread across the country."

Committee members could designate certain drugs as unusually toxic or requiring special knowledge in application. Anesthetic or muscle paralytic agents were addressed early on, and their use could be restricted. Only anesthesiologists, for example, could be certified to use an anesthetic agent such as ether.

Pioneering Efforts

Bellevue's Formulary Committee has helped blaze several trails. Early leaders in antibiotics control, they first took aim at gentamicin, an aminoglycoside antibiotic used to treat a wide variety of bacterial infections. After its introduction, the incidence of gram-negative pathogens rose by 7% in one year. To avoid increasing resistance, the committee instituted an unusual step--requiring that an infectious disease specialist review each prescription, then call the pharmacy to authorize it. With a specialist on call around the clock, the new controls reduced gentamicin usage by approximately 50%, slowing the development of resistance. The successful procedure was used for newer antibiotics, to reduce the development of resistance to the drugs.

As both regulation and quality of medications improved, a wider range of drugs with similar properties and toxicities offered Bellevue another unexplored path--cost control. One new goal became using older drugs as long as possible. "If a new drug has a really impressive advantage, it's not always easy to delete the prior drug," observed Dr. Holzman. Bellevue's committee quickly learned it could "ask for the best prices from a vendor as a selection criterion, get a competitive bid, use their drug for one year and keep seeking the best price."

By the mid-70s, the process included identifying therapeutically equivalent drugs and choosing between them to buy the less expensive medication. "We permitted the pharmacist to fill the prescription with whichever drug was on hand, once they were declared therapeutically equivalent. This was fairly unique at the time," Dr. Holzman said.

Lessons in Frugality

Bellevue, America's oldest public hospital, opened in 1736. Centuries later, its status still demands significant restraints and innovations. Steven DiCrescento, RPh, Director of Pharmacy at Bellevue from 1989 to 2002, recalls intensive training in extreme clinical and fiscal responsibility. "That involved negotiating prices and market-share agreements with manufacturers," he noted. "If a drug was going to be presented to the formulary, you'd have done your homework and gotten an idea of what their contract would look like, so you could try to get a better price."

Rising expenses on a public hospital budget spurred creativity. "Bellevue couldn't turn down patients needing state-of-the-art therapy," Mr. DiCrescento explained. "Looking for any way we could get drugs paid for, we located and learned to tap into drug companies' and federal programs that might cover patients who can't afford their own medications."

With resources always at a premium, Mr. DiCrescento had to think proactively, to avert any potentially serious problem. "If you required 10 pharmacists and only had three, you still had to find ways to order, and provide timely care." One of his effective approaches was establishing interdisciplinary working groups. Cooperation between two clinically expert disciplines--the Pharmacy and Nursing Departments--improved patient care and safety.

Spreading the Knowledge

Currently Director of Pharmacy at NYU Medical Center, Mr. DiCrescento said that Bellevue taught him to support patient safety while thinking economically about managing rising costs, negotiating contracts, recognizing parameters for a new formulary addition and understanding the pharmacoeconomic business model. Today's goals at academic teaching institutions are to provide a balance between patient safety and expense reduction and revenue enhancement. He was able to bring to NYU his prior immersion in cost control, and develop effective new therapeutic strategies that reduced expenses and optimized patient safety.

"I brought that creative mentality and aggressive thinking," Mr. DiCrescento said. His familiarity with budgetary constraints at Bellevue helped him accrue $1 million in potential savings and revenue enhancements, in areas including high acquisition-cost drugs.

At NYU's pharmacy, he has expanded the responsibilities of the kind of interdisciplinary working groups he had established at Bellevue. Four groups (pediatrics, oncology, medicine and surgery) now explore service improvements. "They've begun initiatives on timely delivery of medications, therapeutic guidelines, drug doses, frequency of physician orders and precautions doctors need to be aware of," said Mr. DiCrescento, a member of all four groups.

Former Bellevue Director of Pharmacy Steven Alexander, RPh, MBA, became Pharmacy Director at another New York City public hospital, Elmhurst General, in 1991. "Most private hospitals didn't have large outpatient pharmacies then, but the city hospitals did. At Bellevue, we were early to computerize ours, and also expanded unit dose distribution." Mr. Alexander brought both innovations to Elmhurst, where his previous Bellevue discussions on allowing city hospitals to bill third parties for outpatient medications soon came to fruition.

Bellevue was also one of the first New York hospitals to include a clinical pharmacist on its total parenteral nutrition service--another idea Mr. Alexander transported to Elmhurst. As multiple choices became common within therapeutic classes, he had admired Bellevue for deciding to select one representative drug, rather than all of those in a specific class. By the late '80s, "you had drugs that might be on patent, or unique entities; Bellevue could competitively bid within the class, with its strong formulary committee. This was fairly unusual then," Mr. Alexander said. He recommended the approach to Elmhurst, where he is now Associate Executive Director of Ancillary Services.

Continually Evolving

Like her predecessors, Bellevue's current Director of Pharmacy, Marcelle Levy-Santoro, RPh/MS, continually seeks innovative solutions to a public institution's special circumstances. "In spite of our very tight formulary, Bellevue still spends about $900,000 a year on nonformulary drugs to treat unusual conditions, as well as to fund drugs for several hundred research studies here each year," Ms. Levy-Santoro said. "This expense is somewhat offset by the Indigent Drug Program recently implemented in this pharmacy, which generates $2 million per year."

For each drug used in an investigative study, the P&T committee discusses costs and alternatives, because they'll have to acquire the medication for each nonsponsored clinical trial. "This adds significantly to the expenses of the budget," she noted. "The P&T committee must approve a study even before it goes to the Research committee. Without approval from P&T, the trial can't be approved by the hospital." Decisions about nonformulary drugs are made jointly by the Director of Pharmacy and P&T.
The lessons Ms. Levy-Santoro and earlier pharmacy directors learned from handling Bellevue's strict budget are relevant to any hospital today. "Being required to keep expenses low at a city hospital prepared me to guide the NYU staff towards certain cost savings initiatives, and tie them to patient safety efforts," Mr. DiCrescento said. "Instead of making them separate areas, we are trying to balance costs with safety."

He added that his 13 years as Director of Pharmacy at Bellevue "taught me that we shouldn't be afraid to take on new challenges in an ever-changing environment--and to involve other people, because you can't do it by yourself."

--Carol Milano

 


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